The following procedures have been developed to provide information to applicants with respect to the efficacy standards that will be used to judge data in support of efficacy claims
1. Objectives. a. To field test the effectiveness of a product and thereby obtain a statement on efficacy.b. Greenhouse (plant forcing structures) testing must follow the same steps as field trials.c. The objective(s) statement must identify the agricultural benefit(s), hereafter referred to as agronomic (inclusive of agronomic, horticulture and silviculture), that will be derived from the use of the product.d. An example of an efficacy claim would be "increases grain yields of wheat". Field trails must be designed to measure the parameter identified in the claim. In this example, wheat yields would have to be measured.2. Researchers. a. Support for efficacy claims should include a minimum of two independent studies in each year of testing, one of which should be conducted by an independent researcher. An independent researcher is one who has no formal affiliation with the applicant. Examples of possible independent researchers include government or industry personnel, as well as private collaborators.b. The researcher(s) must provide adequate evidence of credentials to allow an assessment of their capacity and then of the credibility of the studies completed. Typical minimum credentials might be a Bachelor's or higher degree in agriculture or a related scientific field, and previous experience in carrying out scientifically sound field trials or agriculture product performance. The researcher(s) qualifications must be substantiated by a resume.3. Treatments. a. Field trials must be designed and conducted in a scientifically sound manner.b. The following are examples of treatments that would be the minimum required: i. Application of the test product (final formulation) at the rate and by the method specified on the label.ii. A check or no application treatment. (In some instances, it may be necessary to apply the carrier as an additional treatment.)c. Where label instructions specify the need for modified agronomic practices, the following additional treatments are appropriate.i. The company's recommended agronomic program without the test product(s).ii. The company's recommended agronomic program with the test product(s). In instances where a comparison forms the basis of an efficacy claim (eg. "maintains yield while reducing the need for nitrogen by 40 #/acre), the following additional treatments are recommended.iii. Application(s) of the product or agronomic practice that forms the basis for the comparison. In the example cited above, the nitrogen should be applied at varying rates, (i.e. O, 1/4X, X, 2X, etc.) with and without the product or agronomic practice to form the basis for comparison.iv. In some instances it may be appropriate to also apply a product which exhibits a known effect similar to those being claimed for the test product. It is also recommended that initial field trials include applications of the test product at varying rates, (e.g. 1/2X, 2X etc.) so that the optimum rate of application can be determined.4. Duration of Testing. Ideally all tests will be conducted for a minimum of three growing seasons. In cases in which the activity of the product is well-understood, and sufficient scientific rationale exists to predict that the product will be effective on other crops, a single year's data may be sufficient to extend to another crop.5. Location of Testing. Both the developer and users of the product should be aware of agronomic and climatic factors that will influence its performance. For this reason, the Region (indicated in appendix I), shall be recognized and acceptable as related to Mississippi conditions.6. Experimental Design. a. All tests must be replicated and randomized in a scientifically recognized manner that will allow for an appropriate statistical analysis of the data. Although the number of replications will vary with the variability in response, a minimum of 4 replications is recommended. The experimental design shall be uniform among sites.b. When applicable and probably with most products, it will be necessary to carry out the appropriate soil and tissue analyses prior to initiating the field trials.7. Plots or (Greenhouse). Plots must be large enough to allow a meaningful sample to be collected and treatments to be independent from one another. The minimum size of the plot will be dependent upon the crop, the agronomic practice being used and the parameter that is being measured.8. Analysis of Data and Performance Standards.a. Efficacy will be assessed on the basis of the statistical analysis. A 95% confidence interval is considered significant. Each year, 60% of all trials must show a statistically significant positive response in order to support an efficacy claim. Deviations from these requirements may be permitted where sufficient scientific rationale exists.b. Only those studies carried out in accordance with the label instructions will be accepted and must meet the performance standard. For example, if the label clearly states that the product is not effective in soils where the Ph is below 6, only studies carried out on soils where the Ph was greater than or equal to 6 will be considered when determining the overall performance of the product.9. Reporting Procedures (Data Required To Support Registration)a. Introduction: The introduction should identify: ii. the ingredients contained in the product;iii. the active ingredients and the associated guarantees;iv. the suggested mode of action.b. Proposed label: The label shall carry a clear and concise benefit claim and fully describe the manner in which the product is intended for use. In the case of greenhouse application products, the label must show "greenhouse use only". Further labeling requirements are specified in Section 69-24-7 of the Mississippi Soil and Plant Amendment Law.c. Materials and Methods: The description of the experimental procedures shall describe the details of the field trails. The description of the plot (including details on soil types results of initial soil tests, and climatic conditions), the experimental design, the treatments, the agronomic practices used, and the manner in which the samples were collected and assessed are among the details that are considered essential.d. Results and Discussion: This portion of the report shall contain the appropriate summaries of the data and statistical analyses as well as the interpretation of the results. An explanation of any anomalies such as missing values should also be provided.e. In the case of yield data, results must be corrected to a standard moisture. The percent moisture should be included with the raw data.f. The raw data and actual statistical analyses should be provided in appendices.g. Literature Cited: All references should be listed.h. Additional references, to provide background information or technical specifications, are welcome.2 Miss. Code. R. 1-3-05-105
Miss. Code Ann. § 69-24-27.